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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02361723




Registration number
NCT02361723
Ethics application status
Date submitted
29/01/2015
Date registered
12/02/2015

Titles & IDs
Public title
Phase 1a/1b BGB-290 for Advanced Solid Tumors.
Scientific title
A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation, and Expansion Study to Investigate the Safety, Pharmacokinetics, Food Effect, and Antitumor Activities of BGB-290 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
2017-003646-25
Secondary ID [2] 0 0
BGB-290-AU-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: ovarian cancer, fallopian cancer, or primary peritoneal cancer - 60mg BID oral.

Experimental: Breast Cancer - 60mg BID Ora

Experimental: Prostate Cancer - 60mg BID Oral

Experimental: Small Cell Lung Cancer - 60mg BID Oral

Experimental: Gastric Cancer - 60mg BID Oral
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate ([ORR]: Complete Response (CR) + Partial Response (PR)) based on RECIST Version 1.1
Timepoint [1] 0 0
through study completion, an average of 1 year
Primary outcome [2] 0 0
Prostate-specific antigen (PSA) response (for prostate cancer participants only) based on Prostate Cancer Working Group 2 (PCWG2) criteria
Timepoint [2] 0 0
through study completion, an average of 1 year
Primary outcome [3] 0 0
Primary PK 1
Timepoint [3] 0 0
through study completion, an average of 1 year
Primary outcome [4] 0 0
Primary PK 2
Timepoint [4] 0 0
through study completion, an average of 1 year
Primary outcome [5] 0 0
Primary PK 3
Timepoint [5] 0 0
through study completion, an average of 1 year
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
through study completion, an average of 1 year
Secondary outcome [2] 0 0
Duration of response for responders (CR or PR) and duration of SD (defined only for participants whose confirmed best response is CR, PR, or SD.
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [3] 0 0
The number and proportion of participants who achieve objective tumor response (complete response [CR], partial response [PR], and CR+PR) or stable disease (SD).
Timepoint [3] 0 0
through study completion, an average of 1 year

Eligibility
Key inclusion criteria
Key

1. Male or female and at least 18 years of age with a life expectancy of at least 12 weeks.
2. Histologically or cytologically confirmed malignancy that has progressed to the advanced or metastatic stage for which no effective standard therapy is available.
3. BRCA1/2 mutations are not required but enrichment of this participant population is permitted.
4. Eastern Cooperative Oncology Group (ECOG) performance status of = 1.
5. Adequate bone marrow, liver, and renal function.
6. Participants who have histologic or cytologic confirmation of malignancy that has progressed to the advanced or metastatic stage.
7. Eligible participants who have received the prior chemotherapy regimen in the advanced or metastatic setting.
8. Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and throughout the study until 28 days after the last investigational product administration.
9. Able to swallow and retain oral medication.

Key
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants did not receive prior therapies targeting poly-ADP ribose polymerase (PARP).
2. Participants who are not considered to be refractory to platinum-based therapy (e.g., progressive disease at the first tumor assessment while receiving platinum treatment).
3. Participants who have not been treated with chemotherapy, biologic therapy, immunotherapy, or other investigational agent within five times half-lives of the last treatment or within 4 weeks (whichever is longer) prior to starting study drug (or who have not recovered from the side effects of such therapy).
4. Participants who have not undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit.
5. Participants must have recovered from the treatment and have a stable clinical condition before entering this study.
6. Participants who have not received therapeutic radiotherapy to target lesions. 7.Participants who have received local palliative radiotherapy of non-target lesions for local symptom control within the last 21 days must have recovered from any adverse effects of radiotherapy before recording screening symptoms. 8.No untreated brain metastasis or unstable neurologic condition after the completion of radiation, or requiring corticosteroid of > 40 mg prednisone daily equivalent dose to control the symptoms.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/09/2019
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford PK
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Nucleus Network - Melbourne
Recruitment hospital [6] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
5042 - Bedford PK
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Millward, MD
Address 0 0
Linear Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Lickliter JD, Gan HK, Meniawy T, Yang J, Wang L, L... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02361723